Synopsis
Written by industry experts and officials at the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER), this book provides a comprehensive review of FDA’s emerging processes for regulating and approving biological products. An extensive examination of FDA’s regulation of biologic products, from preclinical testing to postmarketing regulatory requirements and from user fees to electronic submissions is presented. It also evaluates the consolidation and transfer of specific biologic product reviews from CBER to CDER.
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Biologics Development: A Regulatory Overview
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Biologics Development: A Regulatory Overview
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Barnett Educational Services / Chi, 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
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Biologics Development: A Regulatory Overview
Published by
Barnett Educational Services / Chi, 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
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Biologics Development: A Regulatory Overview
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Biologics Development: A Regulatory Overview
Published by
Barnett Educational Services / Chi, 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
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Biologics Development: A Regulatory Overview
Published by
Barnett Educational Services / Chi, 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
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Biologics Development: A Regulatory Overview
Published by
Barnett Educational Services / Chi, 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
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Biologics Development: Regulatory Overview
Published by
Barnett Educational Services / Chi, 2004
ISBN 10: 1882615670
ISBN 13: 9781882615674
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